None listed
Conditions
Brief summary
Hypothyroidism is one of the most common endocrine disorders, the treatment of which consists of lifelong replacement therapy with the drug thyroxine. Drug company GlaxoSmithKline recently reformulated their thyroxine tablet and now requires the tablet be taken on an empty stomach. To our knowledge however there is no evidence currently to suggest that food affects gastrointestinal thyroxine absorption. As taking medications on an empty stomach makes patient compliance more difficult this project aims to show that taking thyroxine with food will not affect its absorption in any clinically significant manner.
Interventions
Participants who are taking a standard oral dose of the thyroxine tablet manufactured by GlaxoSmithKline (brand name: Eltroxin) will take their thyroxine tablet orally with food (their meal). Their dosage amount will continue to be what has been their regular dose previous to the commencement of the study as prescribed by their General Practitioner, therefore each patient will be taking an individualised dosage amount between 0.05mg - 0.20mg; dosage frequency will be once daily with food. As app
Participants who are taking a standard oral dose of the thyroxine tablet manufactured by GlaxoSmithKline (brand name: Eltroxin) will take their thyroxine tablet orally with food (their meal). Their dosage amount will continue to be what has been their regular dose previous to the commencement of the study as prescribed by their General Practitioner, therefore each patient will be taking an individualised dosage amount between 0.05mg - 0.20mg; dosage frequency will be once daily with food. As approximately six to eight weeks is required for any changes in thyroid function (i.e. changes in blood Thyroid Stimulating Hormone levels) to be seen, the duration of the Intervention Treatment for each participant will be six to eight weeks.
Sponsors
Associate Professor Dr Patrick Manning
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Participant: has been taking thyroxine tablets for hypothyroidism for a minimum of 8 weeks; thyroxine tablet taken is manufactured by GlaxoSmithKline (brand name: Eltroxin); takes a standard daily dose; >18 years; has a blood TSH level within the normal range of 0.4 – 4.0mu/L at the start of study
Exclusion criteria
Participant: has history of other serious illness, for example active cardiovascular disease; is normally non-compliant with medication; is currently taking other medications that could possibly interfere with thyroxine absorption, for example omeprazole, or calcium tablets; has a blood TSH level not within the normal range of 0.4 – 4.0mu/L at the start of the study
Outcome results
None listed